Regulatory data are hidden in plain sight

The editorial by Doshi and Godlee rightly argues for better communication among regulatory scientists, medical journals, and the public, especially when evidence held by regulators differs from journal publications.1 Watchdog groups, such as the health reform group of Public Citizen, routinely access material posted online by the US Food and Drug Administration, but otherwise these data seem to live in limbo—although publicly available, they remain hidden in plain sight.

Regulatory science data are an important part of the drug information landscape and crucial to the growing progress made by the data transparency movement.

We think that medical school courses (such as research methods, history of medicine) should train students to use regulatory reports and case studies that highlight examples of discrepancies between journal accounts and regulatory reports.

Regulatory agencies have a deeply embedded culture of silence,23 which is in part underpinned by new drug approval budgets heavily reliant on user fees. The debate continues about whether the introduction of user fees in the 1990s constituted “regulatory capture” or accelerated a pre-existing pro-industry pattern.4 Whatever the case, returning to a funding system clearly based on tax dollars would signal a cultural shift that prioritises public safety and transparency. Unfortunately, the current proposals to cut public funding and increase user fees in the US seems to be going in the opposite direction.5

We urge readers to revisit the well known 2004 US Senate testimony of the FDA’s David Graham during the VIOXX scandal.6 Given the current political climate, we fear that regulatory scientists will be further constrained and silenced.